Kornimate/medical-research-clean huggingface dataset:
physiological effects of altering cancer-related inflammation

Conditions: Colon Cancer

Summary: this prospective pilot study will examine whether the previously reported effects of nsaids on colorectal cancer may be modulated through alterations in tissue gene expression, up regulation of local immune cell infiltrates or down-regulation of the systemic inflammatory response.

bowel cancer is the second commonest cause of death from cancer in the uk. of patients who have an apparently curative operation, half unfortunately suffer disease recurrence and die before 5 years. clearly more research is required to improve outcomes in this condition. most current research focuses on antitumour strategies, however the reaction of the patient (host) to the tumour is also important. the host inflammatory responses to the cancer are likely to represent part of this host-tumour relationship. inflammation plays an important role in predicting patients who will die. currently it is not known whether antiinflammatory drugs have any effect on cancer related inflammation detected in the blood or in/around the tumour. aims: we hope to demonstrate that tumour related inflammation in bowel cancer can be altered using anti- inflammatory drugs. this may form the rationale for the use of antiinflammatory drugs to improve prognosis in colorectal cancer patients undergoing surgery. methods: this pilot study will investigate whether simple antiinflammatory drugs can alter markers of inflammation both in the blood and in/around the tumour. patients having bowel cancer surgery will be prescribed one of two anti-inflammatory drugs (aspirin 75mg once daily or ibuprofen 400mg three times daily) for 2 to 3 weeks prior to their operation. blood and tumour samples before and after the treatment will be analysed. if the study's aims are met and cancer-related inflammation can be altered prior to surgery, then a larger scale drug trial will be proposed to demonstrate reduced cancer recurrence and improved survival.

Eligibility criteria:
inclusion criteria: * aged 18 to 75 years old * histologically confirmed colon cancer * evidence of systemic inflammation (c-reactive protein \>10mg/l) * candidate for elective primary curative resection exclusion criteria: * age \ 75yrs * emergency presentation * rectal cancer * distal metastatic disease at presentation * provision of neo-adjuvant chemo-radiotherapy * long-term use of aspirin or anti-inflammatory medications (nsaids, or steroids * hypersensitivity to product or excipients or evidence of previous hypersensitivity reactions such as asthma, rhinitis, angioedema or urticaria in response to aspirin, ibuprofen or other nsaid * intolerance of nsaids/ aspirin due to allergy or side effects * active peptic ulcer disease * previous history of recurrent gastrointestinal bleeding or bleeding/perforation secondary to previous nsaid use * previous treatment for gastrointestinal cancer * alcohol excess (above recommended guidelines) * chronic renal impairment * moderate to severe heart failure * hepatic impairment

Keywords: colon cancer nsaid inflammation
comparing continuous with flash glucose monitoring in adults with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: the present study wants to compare the dexcom g6® continuous glucose monitoring (cgm) system (experimental group) with the freestyle libre flash glucose monitoring (fgm) system (control group). the alertt1 trial will have three phases: a baseline, study, and extension phase. during the baseline phase, eligible patients will be screened for in- and exclusion criteria, wear a blinded dexcom g6® for 28 days, together with their freestyle libre fgm system, and receive a uniform education moment. in the study phase, patients will be randomized into two groups (1:1): the experimental group will use an unblinded dexcom g6® cgm for 6 months, the control group will keep using the freestyle libre fgm system for 6 months. before the 6 month time point is reached, patients in the control group will wear a blinded dexcom g6® cgm for 28 days, together with their freestyle libre fgm. in the extension phase, patients in the initial control group will start using unblinded dexcom g6® for 30 months. the initial experimental group will keep using the unblinded dexcom g6® for the next 30 months.


Eligibility criteria:
inclusion criteria: * signed icf * diagnosis of type 1 diabetes ≥6 months * using freestyle libre fgm system ≥6 months * intensified insulin therapy/insulin pump therapy * hba1c ≤10% * willing to wear the glucose monitoring device \>80% of the time * willing to download glucose monitoring data at regular intervals exclusion criteria: * non-type 1 diabetes participants or diagnosis \<6 months * participant with t1d not on insulin, or on non-intensified insulin therapy * pregnancy or planning pregnancy within next 6 months * severe cognitive dysfunction or other disease which makes sensor use difficult * current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator * abnormal skin at the anticipated glucose sensor insertion sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo) * presence of concomitant pathology that might cause edema at the insertion sites (such as heart failure, liver failure, kidney failure defined as egfr \<30 ml/min \[stage ≥4\]) * beta-cell transplantation and c-peptide positive and/or under immunosuppressive therapy

Keywords: dexcom g6 freestyle libre time in range continuous glucose monitoring flash glucose monitoring
glucose variability and cognition in prediabetes

Conditions: Glucose Metabolism Disorders (Including Diabetes Mellitus); Cognitive Decline; Functional Status; PreDiabetes; Aging; Depression

Summary: this study examines the association of variability in glucose values over a 10-day period with cognitive function and functional status among individuals with prediabetes, aged 50 or older.

type 2 diabetes (t2dm) is now widely considered a major public health epidemic. t2dm is highly prevalent worldwide, is among the leading causes of death, and is an independent risk factor for dementia and less severe forms of cognitive dysfunction. the investigators are utilizing novel technology to understand the role of variability in glucose on neurocognition and functional status among middle-aged and older adults at risk for diabetes. the central hypothesis is that even before diabetes onset, variability in glucose will be associated with worse cognitive function and lower functional status. participants will be asked to wear a glucose monitoring device over a 10-day period in their home environment. assessment of functional status and neurocognitive function, in addition to sociodemographic factors, health habits and mood will also occur over two study visits.

Eligibility criteria:
inclusion criteria: * aged 50 years and older * at least 8th grade education exclusion criteria: * diagnosed type 1 or type 2 diabetes * current use of mediation for diabetes (oral hypoglycemic agents, insulin), or with diabetic properties (e.g., steroids) * chronic disorders (cardiovascular disease, peripheral vascular disease, stroke, transient ischemic attack, chronic kidney disease, past year cancer) * neurological disorders (e.g., parkinson's, epilepsy, multiple sclerosis) * history of dementia or suspected dementia * known hiv * serious mental illness, psychosis, or use of psychotropic medication * heavy alcohol use

Keywords: glucose variability continuous glucose monitoring system (cgms) prediabetes aging physical functioning neurocognition cognitive decline
reactiv8 post market surveillance registry

Conditions: Chronic Low Back Pain

Summary: to gather data on the long-term safety of reactiv8 and identify any residual risks by reporting all serious adverse device effects as well as performance and health care utilization through two years post-implant.


Eligibility criteria:
inclusion criteria: 1. meet the indications for reactiv8 2. willing to sign the informed consent for the registry 3. age ≥ 18 years exclusion criteria: 1. subjects will be excluded from the registry if they are contraindicated for reactiv8.
patient derived cancer cell lines in identifying molecular changes in patients with previously untreated pancreatic cancer receiving gemcitabine hydrochloride-based chemotherapy

Conditions: Pancreatic Ductal Adenocarcinoma; Stage IA Pancreatic Cancer; Stage IB Pancreatic Cancer; Stage IIA Pancreatic Cancer; Stage IIB Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer

Summary: this pilot research trial studies patient derived cancer cell lines in identifying molecular changes in patients with previously untreated pancreatic cancer and are receiving gemcitabine hydrochloride-based chemotherapy. cell lines refer to samples taken from the patient's tumor to grow for many months or years in a laboratory, and can therefore be studied scientifically. studying cell lines in the laboratory may help doctors understand the genetic changes that occur to the tumor during chemotherapy that allows the tumor to resist or grow despite treatment.

primary objectives: i. compare the genetic profile of the tumor after progression has occurred, to the tumor prior to treatment. secondary objectives: i. additional molecular patterns, beyond genetics, will be analyzed, including ribonucleic acid (rna) and protein expression. outline: tissue and blood samples are collected for genetic analysis via sequencing from patients receiving gemcitabine hydrochloride intravenously or gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation. chemotherapy is not part of the protocol. per standard of care, patients receive gemcitabine hydrochloride (iv) the first 3 of 4 weeks (qw 3/4 wk) or gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation iv qw 3/4 wk in the absence of disease progression or recurrence.

Eligibility criteria:
inclusion criteria: 1. suspected or confirmed pancreatic adenocarcinoma, any stage 2. \>18 years of age 3. no prior systemic chemotherapy for pancreatic cancer, or currently undergoing first-line treatment for pancreatic cancer, or completed only first-line treatment for pancreatic cancer 4. a plan to undergo gemcitabine-based chemotherapy at thomas jefferson or a collaborating institution 5. abdominal/pelvic ct scan or mri within 4 months of the study 6. signed study-specific informed consent exclusion criteria: 1. pregnancy 2. prior systemic chemotherapy for pancreatic cancer 3. gender/minority/pediatric inclusion for research
intranasal ketamine versus intranasal fentanyl

Conditions: Multiple Trauma; Pain, Acute

Summary: abstract background: given the inadequate control of pain in patients with injury that refer to the emergency departments, the rapid onset of action of intranasal administration in pain management, and the avoidance of administering opioid medications, the present study aimed at evaluating the effect of intranasal ketamine versus intranasal fentanyl on pain management in isolated traumatic patients materials and methods: the current study was performed on 125 patients that were divided into the following three groups: control group (n = 41), 1 mg/kg intranasal ketamine group (n = 40), and 1μg/kg intranasal fentanyl group (n = 44). then pain scores, hr, rr, bp, and sao2 were recorded at baseline, 5, 10, 15, 30, and 40 minutes after the intervention.


Eligibility criteria:
inclusion criteria: * patients with acute limb trauma, aged 15-65 years, with moderate to severe pain (45 mm; visual analog scale (vas)), with a gcs score of 15, with the systolic blood pressure of lower than 180 mmhg, diastolic blood pressure of higher than 90 mmhg * lack of pregnancy * no history of allergy to ketamine, fentanyl (or opioids), or acetaminophen, * no history of liver diseases, * no acute or chronic structural or functional nasal obstruction diseases, * no history of drug or psychiatric addiction, * no pain medication within the past four hours, * no history of heart disease, * and the presentation of the written consent to participate in the study. exclusion criteria: * a decrease in gcs score to less than or equal to 14, * an elevated systolic blood pressure to higher than 180 mmhg, * a decreased diastolic blood pressure to less than 80 mmhg, * inability to understand the vas pain rating system, * symptoms of acute heart disease and respiratory depression (respiratory rate \<8 / min), * and the patient's dissatisfaction to continue the cooperation in study
effect of renin angiotensin aldosterone system genetic polymorphism on the pharmacological effect of mineralocorticoid receptor antagonists in patients with myocardial infarction

Conditions: Myocardial Infarction

Summary: early treatment of myocardial infarction patients with mineralocorticoid receptor antagonist with help reduces the incidence of cardiac remodeling and development into heart failure. also studying aldosterone synthase (cyp11b2) and mineralocorticoid receptor (nr3c2) gene polymorphisms in egyptian myocardial infarction patients will help tailor medication therapy and optimize therapeutic effects with the least adverse effects.


Eligibility criteria:
inclusion criteria: * st- segment elevation patients. * patients who are candidate for add-on treatment with mineralocorticoid receptor antagonists (mras) to improve cardiac remodeling. * age of 18 years to 80 years. * written informed consent of the subject to participate in the study. exclusion criteria: * contraindications to mineralocorticoid receptor antagonists (mra) including: serum potassium \>5.5 meq/l at initiation; crcl ≤30 ml/minute; concomitant use of strong cyp3a4 inhibitors; concomitant use with potassium supplements or potassium-sparing diuretics. * mild-to-severe valvular stenosis or severe (grade iii/iv) valvular regurgitation * pregnant or nursing women. * non cardiac disorders associated with increased growth factor (e.g., hiv, alzheimer, crohn's disease, cancer, glomerulonephritis, glomerulosclerosis, diabetic nephropathy, muscle atrophy, fibrotic conditions and burns). * patients with chronic heart failure with reduced ejection fraction (lvef \<40%).

Keywords: aldosterone antagonist myocardial infarction cardiac remodeling gene polymorphism remodeling marker stress marker
hydration intervention in children

Conditions: Dehydration in Children

Summary: the investigators are conducting this research study to determine learn how daily habits and fluid choices impact children's health, sleep, cognitive function and mood. the investigators look to determine if a hydration intervention using an alternative beverage may impact these variables in children. maintaining an appropriate level of hydration throughout the day has multiple health benefits. maintaining a desirable hydration status improves overall health and wellbeing (mood, reaction time, sleep quality, cognitive function, etc.) in adults, but negative health and mental effects of hypohydration are not fully understood in an adolescent population. maintaining appropriate hydration in adolescents presents unique challenges with respect to schedule (e.g. the availability of fluid during the school day and after school activities) as well as ensuring the most beneficial beverage choice. adolescents can be very meticulous regarding their preferred beverage (e.g. choosing a sugary drink over water) and parents prefer their children consume the healthiest option for their food and beverages, often times leading to conflict. therefore the purpose/goal of the proposed study is to determine if a hydration intervention using an alternative sweetened beverage will improve hydration and other overall health (e.g. cognitive function, sleep quality, mood etc.) the investigators hypothesize, that by giving children an alternative tasty option, they will consume more fluids which may lead to improving and maintaining their chronic hydration state. implementing a beverage intervention with a sweet alternative option (i.e. creative roots) could improve hydration levels in adolescents. in turn, possibly improving mood, reaction time, sleep quality, and cognitive function. all of which are vital in the overall development of the adolescent.


Eligibility criteria:
inclusion criteria: * males and females * aged 7-12 years old * guardians must also meet the criteria which is that * 1) they shop at whole foods, costco, or trader joe's * 2) they use organic ingredients \& * 3) they check the nutritional content on foods for their children. exclusion criteria: * prior diagnosis of cognitive or learning disabilities * history of chronic kidney disease, * diabetes * sleep disorders * use of medications that may alter water balance (e.g. diuretics, laxatives, antacids, anti-histamines, nsaids, blood pressure medication) * mood and anxiety medications (e.g. antidepressants, anxiolytics, beta-blockers, adhd medications). * other medications that can cause urine color changes include isoniazid, sulfasalazine, metronidazole, nitrofurantoin, amitriptyline, cimetidine, indomethacin, zaleplon, methocarbamol, metoclopramide, warfarin, rifampin, and phenazopyridine * participants who do not like the creative roots beverage
a study to compare the efficacy and safety of valacyclovir hydrochloride ( 256u87 ) versus acyclovir in the treatment of recurrent anogenital herpes infections in hiv infected patients

Conditions: Herpes Simplex; HIV Infections

Summary: to evaluate the safety and efficacy of oral valacyclovir hydrochloride (256u87) vs. acyclovir in the treatment of recurrent anogenital herpes in hiv-infected patients (cd4 greater than or equal to 100).

efficacy variables include the length of the episode, the time to lesion healing, the duration and severity of pain/discomfort, the duration of viral shedding, the proportion of patients with aborted episodes, the proportion of patients requiring extended therapy.

Eligibility criteria:
inclusion criteria patients must have the following: * hiv-infected individual (cd4 = or \> 100) with a history of recurrent anogenital herpes. * signed the consent form or present a signed parental consent form if below 18 years. exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * hepatic impairments as evidenced by a three-fold increase from the upper limit of normal in alanine or aspartate transaminase. impairment of renal function as evidenced by any elevation above the upper limit of normal for serum creatinine. history of hypersensitivity to acyclovir. malabsorption or vomiting that would, in the investigators opinion, potentially limit the retention and absorption of oral therapy. patients with the following are excluded: * hepatic impairment as evidenced by a three-fold increase from the upper limit of normal in alanine or aspartate transaminase. impairment of renal function as evidenced by any elevation above the upper limit of normal for serum creatinine. * history of hypersensitivity to acyclovir. malabsorption or vomiting that would, in the investigator's opinion, potentially limit the retention and absorption of oral therapy. prior medication: excluded: * systemic antiherpes or immunomodulatory therapy within 30 days prior to entry.

Keywords: acyclovir acquired immunodeficiency syndrome aids-related complex antiviral agents anus diseases herpes genitalis
cryotherapy associated with exercise in pain control and physical function in individuals with knee osteoarthritis

Conditions: Osteoarthritis,Knee

Summary: the purpose of this study is to verify the effect of cryotherapy associated with an exercise protocol in pain control, function and quality of life in individuals with knee osteoarthritis

the purpose of this study is to verify the effect of cryotherapy associated with an exercise protocol in pain control, function and quality of life in individuals with knee osteoarthritis. this is a randomized controlled clinical trial, double-blinded. will participate in the study 120 patients with knee osteoarthritis, diagnosed with clinical and radiographic criteria of the american college of rheumatology, of both sexes, aged between 40 and 75 years. the total number of subjects will be divided randomly into three groups of 40 subjects each. during eight weeks, three times per week, each group will receive one type of intervention: exercise protocol for knee osteoarthritis + cryotherapy, exercise protocol for knee osteoarthritis + placebo or exercise protocol for knee osteoarthritis only. a medical certificate will be requested for all participants, showing the capability of practicing physical activities. every individual will have the following variables evaluated one day pre- and one day post-intervention process: pain index (vas), physical function questionnaires (womac) and quality of life (sf-36 questionnaire). three physical function tests will also be carried out: the 30s sitting and standing chair, stair test and fast paced test in 40m. moreover, participants will perform vas in every physical function test. a follow-up period will be performed.

Eligibility criteria:
main inclusion criteria: * diagnosed with knee osteoarthritis based on clinical and radiographic criteria of american college of rheumatology * grade 2 or 3 according to the criteria of kellgren \& lawrence knee osteoarthritis radiographic examination scale. * minimum score of 4 cm in visual analogue scale (total 10 cm) * medical prescription, showing that the participant is capable of performing physical activities main exclusion criteria: * physical therapy within 3 months prior to the research project * corticosteroid injection in the knee (in the previous 6 months) * medical condition (cardiorespiratory, neurological and / or musculoskeletal) * previous ankle, knee or hip surgery

Keywords: osteoarthritis, knee cryotherapy exercise physiotherapy knee